Kornimate/medical-research-clean huggingface dataset:
umbilical vs paraumbilical trocar placement in patients undergoing elective laparoscopic cholecystectomy

Conditions: Incisional Hernia

Summary: the aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy. patients will be randomized into 2 groups: * g1: 12mm umbilical port will be inserted in the umbilical region, with open access and using a hasson port * g2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port. incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.

the aim of this study will be to assess the incisional hernia rate of umbilical or paraumbilical port 12 months after laparoscopic cholecystectomy. patients will be randomized into 2 groups: * g1: 12mm umbilical port will be inserted in the umbilical region, with open access and using a hasson port. pneumoperitoneum will be done by this hasson port. * g2: 12 mm paraumbilical port will be inserted laterally to the midline, with close access and using and optical port, traversing the rectus abdominal muscle. pneumoperitoneum will be previously done using a veress needle. incisional hernia at the level of this port insertion will be assessed by physical examination and, in case of doubst, by ultrasonography, 12 months after surgery.

Eligibility criteria:
inclusion criteria: * elective laparoscopic cholecystectomy * acceptance to participate in the study and sign of informed consent form exclusion criteria: * a gallstone larger than 10mm observed at preoperative ultrasonography * coexistence of umbilical hernia or previous umbilical hernioplasty * previous laparotomy involving the umbilical region * emergency surgery
study of aro-aat in normal adult volunteers

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of aro-aat in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception * willing to provide written informed consent and to comply with study requirements * non-smoker for at least one year * normal lung function * no abnormal finding of clinical relevance at screening * normal aat level at screening visit exclusion criteria: * clinically significant health concerns * regular use of alcohol within one month prior to screening * use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study * recent use of illicit drugs * use of any drugs or dietary/herbal supplements know to interfere with liver metabolism note: additional inclusion/exclusion criteria may apply, per protocol
curvafix® intramedullary system for fixation of pelvic and acetabular fractures, a post market evaluation

Conditions: Pelvic Ring Fracture; Acetabular Fracture; Pelvic Fracture; Pelvic Fracture Acetabulum

Summary: prospective, single arm, post-market evaluation to evaluate the use and performance of the im implant in a post market setting.

this study will evaluate the use and performance of the curvafix im intramedullary system for pelvic fixation in a post-market setting. study participants will undergo follow-up care per institutional practice and data will then be collected from participant medical records. there will be no active patient participation requirements outside of standard of care. any follow up evaluations will be documented and reported through 6 months post-implantation. the study will evaluate secondary surgical interventions as a primary study endpoint. data will also be collected and analyzed for pelvic reduction stability, fracture healing, participant mobility/ambulation, and general health economics.

Eligibility criteria:
inclusion criteria: * subject, or their authorized representative, is willing and able to provide written informed consent, including authorization to release health information * subject has undergone pelvic or acetabular fixation using the im implant and the im implant was placed according to the manufacturer's labeling. * subject's pelvic or acetabular fixation with the im implant occurred within the last 30 calendar days. exclusion criteria: * subject is unwilling or unable to provide written informed consent and/or does not have an authorized representative who can provide consent on their behalf * subject presents with any condition or situation which, in the investigator's opinion, puts the subject at risk, could confound the study results, or may interfere with the subject's participation in the study
cryovalve sg pulmonary human heart valve post clearance study

Conditions: Pulmonary Valve Stenosis; Pulmonary Valve Insufficiency; Aortic Valve Stenosis; Aortic Valve Insufficiency

Summary: the purpose of this study is to collect long-term follow-up data of the cryovalve sg pulmonary human heart valve.

the cryovalve sg pulmonary human heart valve is recovered from deceased human donors, treated with the synergraft® process,which is designed to reduce the donor cells present on the graft. the valve is then cryopreserved for storage until use. removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. however, it is not known how this affects the long-term durability of the valve.

Eligibility criteria:
• retrospective patients o sequential patients implanted with a cryovalve sg pulmonary human heart halve as a ross or rvot reconstruction between february 2000 and march 2004 who were included in the 510(k) data collection will be identified using the following general criteria to aid in selection of patients who are most likely to provide adequate follow-up data: patient is alive and the implanted valve is still in place (has not been explanted). patient is still under the care of the implanting institution or the implanting surgeon. patient was identified as previously providing data for at least one echocardiographic follow-up assessment at a minimum of one year post-implant. * additionally, prospective enrolling centers will have the option to enroll retrospective patients. at these centers, all consecutive patients identified from valve implant data at cryolife, implanted with a cryovalve sg pulmonary valve as a valved pulmonary valve prior to clearance in 2008 will be targeted for inclusion in the retrospective patient data collection. • prospective patients * sequential patients implanted with a cryovalve sg pulmonary human heart halve as a ross or rvot reconstruction after fda 510(k) clearance in february 2008 at selected institutions.

Keywords: pulmonary valve right ventricular outflow tract reconstruction ross procedure
assessment of activity limitation in asthma patients

Conditions: Asthma

Summary: limitation of activity is one of the main item used by composites scores designed to assess the level of asthma control. since this item is systematically subjectively assessed by the patient, the investigators would like to know if these subjective data are correlated with objective data. aims of this study are: 1) to describe what means "limitation of activity" for asthma patients and how they deal with; 2) to describe the objective exercise capacity and characteristics of daily activity in two situations (on exacerbation, out of an exacerbation).


Eligibility criteria:
inclusion criteria: * diagnosis of asthma made by a pulmonologist. * age ≥ 18 yrs-old, \< 65 yrs-old. * moderate or severe exacerbation of asthma (as defined by reddel et al in 2009) at the time of inclusion. exclusion criteria: * all other diseases than asthma that can affect the physical activity (e.g. orthopaedic or neuromuscular disease, cardiac or vascular disease). * pregnancy or suspicion of pregnancy at the time of inclusion. the women who become pregnant during the study period will be excluded.
omega-3 long chain polyunsaturated fatty acid (lcpufa) supplementation in very low birth weight infants for the prevention retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: retinopathy of prematurity (rop) is a blinding disease affecting infants born prematurely. these infants do not have enough essential fatty acids to structurally support the retina, the nerve tissue in the eye which allows us to see. a recent study showed that giving omega-3 (n-3) fatty acids to these infants soon after birth made them less likely to need invasive treatments for eye disease. this research trial will give young infants born prematurely n-3 fish oil treatment and look at how this changes factors in the blood that promote disease. detailed blood studies comparing infants with and without rop will be performed and the infants will be followed over time to assess their eye development.

approximately 517,000 infants are born prematurely every year. as low birth weight and premature infants are surviving longer, they are at risk of developing severe retinopathy of prematurity (rop). rop is a disease of the eye affecting prematurely-born babies. it is thought to be caused by disorganized growth of retinal blood vessels which may result in scarring and retinal detachment. rop can be mild and may resolve spontaneously, but it may lead to blindness in serious cases. rop is the leading cause of irreversible childhood blindness in the united states. as such, all preterm babies are at risk for rop, and very low birth weight is an important risk factor. researchers have found that increasing omega-3 fatty acids and decreasing omega-6 fatty acids in the diet of mice with eye disease similar to rop had reduced areas of blood vessel loss and abnormal blood vessel growth. these findings represent new evidence suggesting the possibility that omega-3 fatty acids act as protective factors in diseases that affect retinal blood vessels. omega-3 fatty acids make compounds that protect against the growth of abnormal blood vessels by preventing inflammation. in two european studies, this treatment decreased the risk of needing laser treatment in the eye for rop. this study has not yet been repeated in the united states. the purpose of this study is to learn how omega-3 fatty acid supplementation in low birth weight infants changes the blood profile of infants receiving this nutritional treatment. infants are enrolled in this study shortly after birth and receive iv and/or oral supplementation until they are full term or the retinal blood vessels have completely developed, shortly after term. once the treatment is over, these infants will continue to be followed for growth and development of their eyes.

Eligibility criteria:
inclusion criteria: * infants born less than or equal to 30 weeks gestation or less than 1500 g at birth exclusion criteria: * patients with liver disease as tested by liver function tests (lfts) * ≤ 500 grams birthweight

Keywords: rop premature infant
comparison of two dose adjustment strategies of a human milk protein fortifier in preterm infants

Conditions: Weight Gain

Summary: the primary objective is to compare weight gain (g/day) of infants receiving new protein fortifier (pf) according to a blood urea nitrogen (bun)-driven fortification regimen to weight gain (g/day) of infants receiving pf according to a weight-driven fortification regimen (standard of care) over a 21 day period.


Eligibility criteria:
inclusion criteria: * gestational age in weeks: 23 weeks 0 days and 31 weeks 6 days. * birth weight less or equal to 1500 g * minimum enteral intake of 150-160 ml/kg/d fortified hm * parents, liable parent, or legal representative (lr) if applicable are willing and able to sign written informed consent and written informed consent is obtained prior to trial entry exclusion criteria: * infants with weight z-score \< -2 sd, based on the fenton growth chart (fenton 2013) * intra-ventricular hemorrhage (grade 3-4) determined using cranial ultrasonography or periventricular leukomalacia. * renal disease determined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased creatinine. * cholestasis (total bilirubin \> 5 mg/dl or 85 umol/l and direct bilirubin \> 20% of total bilirubin) associated with one or more abnormal liver function tests (ast, alt, or ggt). * major congenital malformations that may impact ability to accept enteral feedings (i.e., severe cleft palate, etc.). * suspected or documented systemic or congenital infections (i.e., human immunodeficiency virus, cytomegalovirus, etc.). * evidence of cardiac, respiratory, endocrinologic, hematologic, gastrointestinal, or other systemic diseases that may impact growth, e.g.,: * nec grade above or equal to 2 * uncontrolled sepsis * suspected or documented maternal substance abuse: * born to mothers who smoked \> 10 cigarettes per day during pregnancy * born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or heroin) or alcohol (\> 3 alcoholic beverages per week) during pregnancy * subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol * infants who have received any experimental treatment or received any other investigational intervention (procedure or product) unrelated to this trial, prior to enrollment
bioimpedance and arterial distension

Conditions: Hypertension

Summary: the overall objectives were to investigate if characteristic dimensions for tissue and vessels determined from measured bioimpedance spectra would provide the same values as dimensions determined from mr images of the upper arm and verify that temporal variations of impedances could be converted to blood pressure.

it is emphasized that measurements of pulse wave velocity was not a part of this trial, which implies that only uncalibrated blood pressures could be measured. the specific objectives were: 1. to determine conductivities and permittivities in the spectral region from 1 khz to 1 mhz for persons with: (a) a normal distribution of fat and muscles, (b) exceptionally thick layers of subcutaneous fat, and (c) exceptionally thin layers of subcutaneous fat. both sexes should be represented. 2. to verify that temporal variations synchronous with the heartbeat could be measured on all three groups. hypotheses: a. that experimentally in vivo determined electrical parameters for tissues would differ considerably from theoretical values and from values measured in vitro experiments. b. that the variations of the electrical parameters would exhibit little variation from person to person. c. those simple experimental relations can be established for the electrical parameters by including a simple vascularization model. d. that it is possible to measure temporal variation of the impedance, which are synchronous with the heartbeat. e. that the measured values would facilitate the calculation of the differential blood pressure with accuracies better than 10 mmhg.

Eligibility criteria:
inclusion criteria: * age 18 - 80 years * mental ability to understand information to test subjects exclusion criteria: * serious illness * allergic reactions to ecg or emg electrodes * mentally unstable or unable to perceive instructions * metal implants * claustrophobia * disqualified for mr scanning * pregnant

Keywords: impedance electrical tissue excitation frequency arterial distension distension wave form
transcultural validation of activities scale for kids (ask)

Conditions: Cerebral Palsy and Healthy Individuals

Summary: the activities scale for kids performance (askp) is one of the few self-assessment questionnaires in pediatric rehabilitation that measures child perception in performance of daily routine activities. askp is composed of 30 questions designed to explore activities and participation in children and teenagers with musculoskeletal disorders. scores assess level of physical ability, identify appropriate treatment and monitor changes over time. we recently undertook the cross-cultural validation to achieve a culturally adapted italian version of askp: the italian version is now to be tested on italian children.

the purpose of the study isto test the psychometric properties of the italian version of the askp assessment scale, in a representative sample of individuals with pci. ask p will be administered on a sample of individuals belonging to the population of children and / or adolescents with diplegia and hemiplegia as a consequence of pci. we will perform comprehensive descriptive analysis of the data collected as well as the measurement of the degree of reliability of the italian version of the scale. the aim is to obtain an estimate of askp reliability obtained through transcultural validation. additionally, we will submit the askp on a control group of typical development children in order to test its ability to discriminate between different skill levels.

Eligibility criteria:
inclusion criteria: * italian nationality exclusion criteria: * moderate or severe cognitive impairment; * linguistic barriers

Keywords: cross-cultural comparison disability evaluation self-assessment child adolescent
assessment of transcatheter and surgical aortic bioprosthetic valve thrombosis and its treatment with anticoagulation

Conditions: Prosthetic Valve Thrombosis

Summary: this is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. the study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.

patients with a history of bioprosthetic valve replacement undergo cardiac contrast ct imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. the imaging studies will be performed at least 48-hours after bioprosthetic valve replacement. patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy, followed by repeat contrast ct of the chest and transthoracic imaging. repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy. i

Eligibility criteria:
inclusion criteria: * presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment * age 18 years or older * ability to provide informed consent and follow-up with protocol procedures. exclusion criteria: * renal insufficiency (creatinine \> 1.5 mg/dl) * known allergy to iodinated contrast agents
the use of renal guard system in patients undergoing crt implantation

Conditions: Acute Kidney Injury

Summary: the purpose of this study is to determine whether the use of renalguard system which creates high urine output with fluid balancing may prevent contrast induced nephropathy in patient undergoing cardiac resynchronization therapy (crt) implantation.


Eligibility criteria:
inclusion criteria: 1. eligible for crt implantation 2. estimated gfr \< 60ml/min/1.73m2 exclusion criteria: 1. on dialysis 2. sensitivity to furosemide 3. contraindication for urinary catheter 4. pregnancy

Keywords: resynchroniztion therapy kidney contrast media prevention
turkish version of digital eye strain questionnaire (desq)

Conditions: Cultural Adaptation; Reliability; Validity; Adults; Eye Strain

Summary: the aims of this study were to perform cultural adaptation of the desq and provide information regarding the factor structure, reliability and validity of the instrument in turkish speaking adults.


Eligibility criteria:
inclusion criteria: * between the ages of 18-65 years * people who spend two or more continuous hours a day on their digital devices (computer, tablet, smartphone) or use more than one device exclusion criteria: * history of ophthalmic surgery or active ocular disease * participants who did not understand the instructions or did not sign a consent form were excluded
neoadjuvant carboplatin, weekly abraxane and trastuzumab in her2+ breast cancer

Conditions: Breast Cancer

Summary: q3week carboplatin with weekly abraxane and trastuzumab as neoadjuvant therapy in resectable and unresectable her2+ (stage iia-iiib) breast cancer

our goal is to develop an induction chemotherapy regimen that will have a pcr rate above 50% in her2+ patients without exposing patients to the toxicity of an anthracycline-based regimen. a minimum of 60 evaluable patients will be accrued to the study. we are assuming an observed pcr (or near pcr) rate of 70%. assuming no more than 10% of patients will be inevaluable for the primary endpoint (pcr), we will have at least 54 evaluable patients. with this number, we will have 90% power, with a 1-sided alpha error of 0.05, to demonstrate a pcr rate exceeding 50% for our novel regimen.

Eligibility criteria:
inclusion criteria: * histologically documented adenocarcinoma of the breast * anc \> 1000 cells * female; age \> 18; zubrod ps 0-1 * platelets \> 100,000 * stage iia-iiib disease * total bilirubin \< or = uln * no evidence of metastatic disease not pregnant or lactating * no prior systemic therapy for this breast cancer * serum creatinine \ 30 ml/min * serum alt \< 2.5 x uln * er, pr and her2 status required * lvef (muga/echo)wnl * no baseline \> 2 neuropathy * hemoglobin \> 9.0 gm/dl * her2+, defined by ihc 3+ or fish ratio \> 2.0

Keywords: breast cancer
brain activity in adults with adhd during neuropsychological tasks

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Summary: the aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against adhd.

attention deficit hyperactivity disorder (adhd) is one of the most prevalent psychiatric disorders in children and adolescents. it is characterized by inattentive, hyperactive, impulsive behaviour and neuropsychological deficits. in 40-60% of cases emerge in childhood and persists into adulthood. the aim of the study is to investigate the response on cognitive testing of healthy persons compared to adults with or without medication against adhd. as a secondary endpoint a more robust diagnosing method combining advanced imaging methods with neuropsychological evaluation is tested. neuropsychological testing, functional mri and spectroscopy will be performed. statistical analysis will assess differences in the functional magnetic resonance imaging, spectroscopy and neuropsychological evaluation results between three groups: 1) group of healthy volunteers, 2) participants with adhd with medication and 3) participants with adhd without medication.

Eligibility criteria:
inclusion criteria: * participant is between 20-55 years old * participant is not pregnant exclusion criteria: * participant is not able to consent him/herself * suspected or proven pregnancy * nursing * neurological diseases that could interfere with a diagnosis of adhd * psychiatric comorbidity under treatment * previous history of psychiatric medication * substance abuse * intelligence quotient\<75 * claustrophobia * electrical simulator nerve or bone * implanted medication infusion pump * cerebral aneurysm clips * unstable medical condition